FHI 360 Global Health and Population Research, Durham, North Carolina.
ASTRA Consulting and Center for AIDS prevention Studies (CAPS), Department of Medicine, San Francisco, California, USA.
AIDS. 2023 May 1;37(6):957-966. doi: 10.1097/QAD.0000000000003494. Epub 2023 Jan 25.
HIV remains a significant burden, despite expanding HIV prevention tools. Long-acting injectable cabotegravir (CAB-LA) is a new preexposure prophylaxis (PrEP) product. We reviewed existing evidence to determine the efficacy and safety of CAB-LA as PrEP to inform global guidelines.
Systematic review and meta-analysis.
We systematically reviewed electronic databases and conference abstracts for citations on CAB-LA from January 2010 to September 2021. Outcomes included HIV infection, adverse events, drug resistance, pregnancy-related adverse events, and sexual behavior. We calculated pooled effect estimates using random-effects meta-analysis and summarized other results narratively.
We identified 12 articles/abstracts representing four multisite randomized controlled trials. Study populations included cisgender men, cisgender women, and transgender women. The pooled relative risk of HIV acquisition comparing CAB-LA to oral PrEP within efficacy studies was 0.21 (95% confidence interval: 0.07-0.61), resulting in a 79% reduction in HIV risk. Rates of adverse events were similar across study groups. Of 19 HIV infections among those randomized to CAB-LA with results available, seven had integrase strand transfer inhibitor (INSTI) resistance. Data on pregnancy-related adverse events were sparse. No studies reported on sexual behavior.
CAB-LA is highly efficacious for HIV prevention with few safety concerns. CAB-LA may lead to an increased risk of INSTI resistance among those who have acute HIV infection at initiation or become infected while taking CAB-LA. However, results are limited to controlled studies; more research is needed on real-world implementation. Additional data are needed on the safety of CAB-LA during pregnancy (for mothers and infants) and among populations not included in the trials.
尽管 HIV 预防工具不断扩展，但 HIV 仍然是一个重大负担。长效注射用卡替拉韦（CAB-LA）是一种新的暴露前预防（PrEP）产品。我们回顾了现有证据，以确定 CAB-LA 作为 PrEP 的疗效和安全性，为全球指南提供信息。
系统评价和荟萃分析。
我们系统地检索了电子数据库和会议摘要，以获取 2010 年 1 月至 2021 年 9 月期间关于 CAB-LA 的引文。结果包括 HIV 感染、不良事件、耐药性、妊娠相关不良事件和性行为。我们使用随机效应荟萃分析计算了汇总效应估计，并以叙述性方式总结了其他结果。
我们确定了 12 篇文章/摘要，代表了四项多中心随机对照试验。研究人群包括跨性别男性、跨性别女性和 transgender 女性。在疗效研究中，与口服 PrEP 相比，CAB-LA 预防 HIV 感染的合并相对风险为 0.21（95%置信区间：0.07-0.61），HIV 风险降低 79%。各研究组的不良事件发生率相似。在接受 CAB-LA 随机分组且结果可用的 19 例 HIV 感染者中，有 7 例存在整合酶链转移抑制剂（INSTI）耐药。妊娠相关不良事件的数据很少。没有研究报告性行为。
CAB-LA 预防 HIV 感染的效果非常好，安全性问题较少。对于那些在开始时患有急性 HIV 感染或在服用 CAB-LA 期间感染的人，CAB-LA 可能会增加 INSTI 耐药的风险。然而，结果仅限于对照研究；需要更多关于实际应用的研究。还需要更多关于 CAB-LA 在妊娠期间（对母亲和婴儿）以及试验中未包括的人群中的安全性的数据。
